Human Subjects Division/Institutional Review Board

To perform imaging research involving human subjects, various approvals must be obtained prior to the initiation of research projects. Approvals applied to your project may vary depending on the nature of the study and imaging modalities proposed in your research protocol. The principal investigator is responsible for receiving all approvals prior to the execution of research. General guidelines and examples are described below. See links for specific guidelines. Certain exemptions also exist.

 

Institutional Review Board (IRB)

Examples:  Investigational use of ultrasound, MRI. Research use of imaging information obtained as a part of standard patient care.

 

Minimal-Risk IRB

Example:  Retrospective chart review.

 

 IRB and RSO

Examples:  Investigational use of CT, radiographs, fluoroscopy.

 

IRB, RSO, and FDA-UW RDRC

Basic science research involving radioactive materials (e.g., PET tracers) as defined in the RDRC regulations, not intended for diagnostic or therapeutic purpose.

Examples: [F-18]FLT PET, [F-18]FMISO PET.

 

IRB, RSO, and FDA IND

Investigational use of new drugs (e.g., tracers) requiring an Investigational New Drug Application (IND) defined by FDA.  Research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.

Examples:  [F-18]FES PET, [F-18]FLT PET, [F-18]FMISO PET, new MRI contrast agent, new ultrasound contrast agent.

 
Links:

UW IRB:  Institutional  Review Board Committee approval (UW Human Subject Division)

WIRB: New industry-sponsored clinical trials 

Fred Hutchinson Cancer Research Center (FHCRC) IRB

Seattle Children's Hospital (SCH) IRB

RSO:  Radiation Safety Committee approval (UW Environmental Health and Safety, FHCRC

, SCCA, Radiation Safety Office)

 

FDA RDRC

: Radioactive Drug Research Committee program

 

FDA IND

: Center for Drug Evaluation and Research

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